Shoulder Fractures | Effect of PTH(1-34) Treatment on Fracture Healing in Vivo
Shoulder Fractures research study
What is the primary objective of this study?
The purpose of the study is to investigate, whether PTH(1-34) is able to promote fracture healing in postmenopausal women with fractures of the hip or shoulder.
Who is eligible to participate?
Inclusion Criteria: - Acute new osteoporotic trochanteric or collum chirurgicum fracture - Postmenopause Exclusion Criteria: - Calcium metabolic disease other than osteoporosis - Diseases known to affect calcium homeostasis - Dementia - Hypersensitivity to drug or other components of medication - pre-existing hypercalcemia - Decreased kidney function - Increased alkaline phosphatase - Prior external radiation therapy or brachytherapy of the skeleton - Skeletal malignancies or bone metastases - Alcohol and/or drug abuse - Systemic treatment with corticosteroids within the last four weeks - Non-cooperating patients - Patients who do not speak and understand the danish language
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:rhPTH(1-34)Injection of 20 micrograms per day in eight weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Femur PTH(1-34)24 participants with trochanteric fractures will be assigned to Forsteo (PTH(1-34)) treatment
Femur Control24 participants with trochanteric fractures will be assigned to "no treatment"
Humerus PTH(1-34)24 participants with collum chirurgicum fracture will be assigned to Forsteo (PTH(1-34)) treatment
Humerus Control24 participants with collum chirurgicum fracture will be assigned to "no treatment".
Start Date: October 2008
Completed Date: September 2010
Phase: Phase 2
Primary Outcome: Radiological evaluation of healing
Secondary Outcome: Biochemical bone markers
Study sponsors, principal investigator, and references
Principal Investigator: Peter Schwarz, MD, DMSci
Lead Sponsor: Glostrup University Hospital, Copenhagen
Collaborator: The Danish Medical Research Council